Galecto Resumes Recruitment in Phase 2b Global GALACTIC-1 Trial of GB0139 for Idiopathic Pulmonary Fibrosis
GALACTIC-1 is a 52-week randomized, double-blind, multicenter, parallel, placebo-controlled Phase 2b trial being conducted across more than 100 centers globally, investigating the safety and efficacy of Galecto’s lead inhaled compound, GB0139, in up to 210 patients with IPF. The revised trial design retains the same statistical powering to assess the primary endpoint of forced vital capacity (FVC) decline over 52 weeks.
“We are pleased to continue our Phase 2b GALACTIC-1 trial of GB0139 in IPF patients. We believe the 3 mg dose of GB0139, as a single agent, has the potential to be an effective and potentially life-changing treatment. In our previous study of GB0139 in IPF patients, we showed that the 3 mg dose is well-tolerated and easy to administer for the patients. We observed target engagement at that dose level, with a decrease in lung macrophage Galectin-3 levels, as well as reduction in a number of fibrosis biomarkers, including YKL-40, PDGF, and PAI-1. Additionally, we recently announced the results of GB0139 in COVID-19 patients with compromised lung function, which confirmed that the compound was well-tolerated and showed target engagement and highly relevant biological effects,” said Dr. Hans Schambye, CEO of
GB0139 is the world’s first small molecule galectin-3 inhibitor studied in man. The compound is not taken up via the oral route and is being developed as an inhaled therapeutic in Idiopathic Pulmonary Fibrosis (https://clinicaltrials.gov/ct2/show/NCT03832946). Early phase studies have shown that inhalation of GB0139 in healthy volunteers and in IPF patients is well tolerated, and the phase 2a IPF trial showed significant effects on several biomarkers linked to worse outcomes in IPF.
Galecto is a clinical stage biotechnology company incorporated in the U.S. that is developing small molecule-based galectin inhibitors and the collagen cross-linking enzyme, LOXL2, inhibitors. Galecto has multiple clinical programs in fibrosis and cancer focused on galectin-3 and LOXL2, including an inhaled galectin-3 modulator (GB0139) currently in a phase 2b trial for the potential treatment of idiopathic pulmonary fibrosis. The company’s pipeline also includes an orally active galectin-3 inhibitor (GB1211) that is expected to be part of (i) a phase 2 trial for the potential treatment of NSCLC in combination with an anti-PD1 product and (ii) a phase 1b/2 trial in liver cirrhosis, as well as an orally active LOXL2 inhibitor (GB2064) that is expected to part of a phase 2 trial for the potential treatment of myelofibrosis. It is anticipated that enrollment for all of these trials will be initiated in 2021.
Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties. Such forward-looking statements include statements about the GALACTIC-1 trial, including plans for resuming enrollment of patients, the timing of completing enrollment and releasing topline data, as well as GB0139’s potential (including the safety and effectiveness of the 3 mg dose). The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. For such statements,
|For more information, contact:|
|Hans Schambye, CEO|
|+45 70 70 52 10|
|+1 617 430 7577||+44 7483 284 853|
Source: Galecto, Inc.